Acist RXi® Mini System Overpack
RXi Mini System, p/n 801075-001 Processing Unit, Navvus Interface, Mounts, and Accessory Box (Power Cord and Cables)
4manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
Record
| Listed by | Acist Medical Systems, Inc., United States |
|---|---|
| FDA product code | DRQ |
| Device type | Amplifier And Signal Conditioner, Transducer Signal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2060 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K172216 |
| Record published | 2019-05-06 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 018599 | In distribution | |
| 018599 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Labsystem™ PRO | Boston Scientific Corporation | 53 |
| RXi® Mini Navvus Interface Cable | Acist Medical Systems, Inc. | 3 |
| IBP Module | Philips Medizin Systeme Böblingen GmbH | 1 |
| Acist RXi® Mini Mount | Acist Medical Systems, Inc. | 1 |
| Acist RXi® Mini Navvus Interface | Acist Medical Systems, Inc. | 1 |
| Monitor Input Cable, Mikro-Cath to EP-Tracer System | Millar LLC. | 1 |
| IDS With Intergrated MIB | Draeger Medical Systems, Inc. | 1 |
| Pressure Control Unit PCU-2000 | Millar LLC. | 1 |
| MIB II Protocol Converter | Draeger Medical Systems, Inc. | 1 |
| Acist RXi® Mini Processing Unit | Acist Medical Systems, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172216 | 2017-08-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.